BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    ORAcollect®•Dx

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327599893·Le Fort I plate right

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694020206·FPS 2.7mm x 45mm Standard Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694074223·FPS 2.7 x 45mm Screw Sterile Qty 2

    V-14 CONTROL WIRE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRIAGE TOX DRUG SCREEN, CATALOG #94000

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AGC DA2000 KN TIB BRG 71/75X8

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·April 9, 2026

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC.·Product code NBW·October 20, 2008

    ARTERIAL CANNULA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DQR·August 16, 2011

    RESTYLANE, RESTYLANE /00567501/

    FDA Adverse Event
    Injury ·Q-MED·Product code LMH·July 3, 2013

    VANGUARD ROCC POR FEM S55 R

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code MBH·January 22, 2026

    VANGUARD ROCC POR FEM S57.5 L

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code MBH·January 22, 2026

    VANGUARD ROCC POR FEM S57.5 L

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBH·May 13, 2025

    TINBN VANGUARD INT PS ANAT FM R 75MM

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code MBH·June 4, 2025

    VANGUARD ROCC POR FEM S55 R

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBH·June 4, 2025

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023